Myopia Progressing
Conditions
Keywords
Myopia,Probiotics,Gut microbiota
Brief summary
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
Detailed description
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
Interventions
BIOLOGICALInvestigational Bifidobacterium Preparation MR-61
Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.
OTHERPlacebo for MR-61
Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Myopia is defined as spherical equivalent (SE) ≤ -0.5D. 2. Aged between 3 and 18 years, with no restriction on gender. 3. Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D. 4. The subject has sufficient compliance with the study follow-up; the subject or their guardian has the intention to receive treatment and has signed the informed consent form.
Exclusion criteria
1. Presence of other concomitant ocular diseases; 2. Abnormal findings on clinical slit-lamp examination; 3. Existence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases; 4. Individuals with abnormal intraocular pressure or abnormal axial length of the eye; 5. Either or both parents having a spherical equivalent (SE) ≤ -6.00D; 6. Other conditions inconsistent with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spherical Equivalent Refraction | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The change in spherical equivalent refraction (SER) from baseline to each follow-up visit, measured in diopters (D). SER is calculated as the spherical power plus half of the cylindrical power. A negative change indicates an increase in myopia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Binocular Anisometropia | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The difference in spherical equivalent refraction between the two eyes, measured in diopters (D). |
| Change in Axial Length | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The growth value of ocular axial length, measured in millimeters (mm). |
| Change in Anterior Chamber Depth | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The change in depth of the anterior chamber of the eye, measured in millimeters (mm). |
| Change in Lens Thickness | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The change in thickness of the crystalline lens, measured in millimeters (mm). |
| Change in Vitreous Cavity Depth | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The change in depth of the vitreous cavity, measured in millimeters (mm) |
| Change in Far Phoria Degree | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The degree of heterophoria for distance vision, measured in prism diopters (PD). |
| Change in Corneal Curvature | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The change in corneal curvature (keratometry), measured in diopters (D). |
| Score on the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) | Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | Visual quality and vision-related quality of life is assessed using the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25). The overall composite score ranges from 0 to 100, where a higher score represents better visual function and quality of life. |
| Score on the Montreal Cognitive Assessment (MoCA) | Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a widely used screening test for cognitive impairment. The total score ranges from 0 to 30, with a score of 26 or higher considered normal. As probiotic supplementation may influence cognitive function, this will be considered in the interpretation of results. |
| Score on the Gastrointestinal Symptom Rating Scale (GSRS) | Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | Gastrointestinal symptoms are assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire covering reflux, abdominal pain, indigestion, diarrhea, and constipation. Each symptom is rated on a scale from 0 (no discomfort) to 6 (very severe discomfort). A higher total or subscale score indicates more severe gastrointestinal symptoms (worse outcome). As probiotic supplementation may influence gastrointestinal function, this will be considered in the interpretation of results. |
| Score on the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) | Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | Participant adaptation and overall quality of life are assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF), a validated generic quality of life instrument. It covers physical health, psychological health, social relationships, and environment domains. The total score is transformed to range from 0 to 100, where a higher score indicates a better quality of life and better adaptation. As probiotic supplementation may influence overall well-being, this will be considered in the interpretation of results. |
| Change in gut microbiota composition and diversity assessed by 16S rRNA gene sequencing | Fecal samples collected at baseline, 3, 6, 12, and 25 months post-intervention for sequencing analysis. | Fecal samples collected before and after intervention are analyzed using full-length 16S rRNA gene sequencing. Key metrics include changes in alpha diversity indices (e.g., Shannon Index, observed species), beta diversity (e.g., weighted/unweighted UniFrac distance), and relative abundance of specific bacterial taxa (e.g., phylum Firmicutes/Bacteroidota ratio, genus Bifidobacterium). |
| Change in concentrations of fecal and serum metabolites | Fecal and blood serum samples collected at baseline, 3, 6, 12, and 25 months post-intervention for metabolite analysis. | Targeted metabolomic analysis is performed on fecal and blood serum samples. Concentrations of specific metabolites (e.g., short-chain fatty acids, bile acids, or inflammatory cytokines) are measured and reported in nanomolar (nM) or picograms per milliliter (pg/mL) concentrations, as applicable. |
| Change in Near Phoria Degree | Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention. | The degree of heterophoria for near vision, measured in prism diopters (PD). |
Countries
China
Contacts
Primary ContactYifeng Yu, Ph.D
Outcome results
None listed